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Analysis of the Characteristics of Aerosol and Preformulation Research

2021-09-06
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Aerosol is a dosage form of medicine. It is a dispersion system composed of fine liquid droplets or solid particles (dispersed inner phase) in air or mixed gas (dispersed outer phase). The dispersed ions are extremely small, and the diameter is from 1 to hundreds of nanometers. , Generally divided into high, medium and low dispersed internal phases according to the average diameter of dispersed internal phase ions. The aerosol is easy to use, has the functions of rapid onset and accurate positioning. In order to clarify the requirements of clinical treatment and provide a basis for designing a reasonable aerosol prescription, preformulation research is required.

Medicilon has been offering high quality analytical testing services to the pharmaceutical industry for decades. We offer a wide range of quality control testing services to support drug research, registration and production. Biopharmaceutical companies also use many of the same services and Medicilon has also added new services to accommodate their unique needs (detailed in the following section).

Aerosol refers to a preparation in which medicine and a suitable propellant are jointly enclosed in a pressure-resistant closed container with a special valve system, and the valve system is lifted during use to eject the contents under the pressure of the propellant. The aerosol for treating asthma can make the drug particles directly enter the lungs, and it can take effect immediately after inhalation, which has quick-acting and positioning effects. Since the aerosol is clean and sterile in the container, and the container is impermeable to light and water, the stability of the drug can be increased. When aerosol is used, the dose can be accurately controlled by using a quantitative valve, and the aerosol spray is convenient to use, and the drug can avoid the destruction of the gastrointestinal tract and the first pass effect of the liver. Medicilon is a pre-clinical CRO company. According to the characteristics of the dosage form, combined with the physical and chemical properties and stability of the drug, it can consider the production conditions and equipment, conduct process research, initially determine the preparation process of laboratory samples, and establish the corresponding process Control indicators.

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preformulation research

However, the production cost of aerosols is relatively high, because aerosols require pressure-resistant containers, valve containers and special production equipment, and some aerosols are more complicated in use and operation. Inhaled aerosols, because the drugs settle in the cavities of the respiratory organs, are lost in the mouth and pharynx, and escape due to exhalation and inhalation, so the percentage of the main drug that actually enters the alveoli and is absorbed is not high , This is the shortcoming of aerosol. In addition, the propellant is highly volatile, so it has a cooling effect. It can cause discomfort and irritation after repeated use on injured skin. The chlorofluoroalkane propellant can sensitize the heart and cause heart rhythm at a certain concentration in the animal or human body. Abnormal.

Preformulation research content of aerosol

The preformulation research of aerosols mainly includes: determining the disease location, disease severity, and dosage required for treatment of the drug, investigating the physical and chemical properties of the drug, such as surface tension, solubility, crystallization behavior, and stability, and judging the drug formulation Possibility to form an aerosol.

(1) Determine the site of action and dose of the drug

Aerosol drugs are administered under the tongue, nasal cavity or throat according to the needs of clinical treatment. Some drugs do not. The physiological activity of the drug is strong or weak, so the therapeutic dose is small or large. These requirements for drugs are manifested in different strengths in formulation design and molding technology, and two-phase or three-phase aerosols can be selected according to specific conditions.

(2) Investigate the physical and chemical properties of the drug

The extracts of some medicines are large in volume, low in activity, mixed with many impurities, complex in composition, and poor in stability, so it is difficult to form, even if it is barely formed, its stability is difficult to guarantee. By studying the physical and chemical properties of the medicine and comparing the characteristics of the aerosol formulations, the gap between these properties and the properties required for molding can be found. By adding propellants, co-solvents, surfactants and other additives, these gaps can sometimes be narrowed until it is close to the requirements of molding, but some cannot. Therefore, it is possible to judge the molding possibility of the medicine made into aerosol based on these, and then decide whether to choose the aerosol.

The aerosol should be prepared in a bacteria-free environment to prevent the liquid from being contaminated. Moreover, the difficulty in the development of aerosols is that there are many factors that affect the quality of the product, especially for suspension aerosols. In addition to the preformulation factors such as the attributes of raw and auxiliary materials, preformulation composition and dosage, the tank body, especially the valve and actuator It’s also very big. In the development of aerosols, preformulation studies should be conducted to provide a basis for selecting and designing appropriate routes of administration, drug formulations, preformulation, processes and quality control, so that aerosols are safe, effective, stable, convenient and easy to apply. The purpose of quality control.

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